in Black patients, while one study has suggested that a higher virological failure rate in such patients could not be explained by lower adherence or socio demographic factors. Another study was designed to equalize variables such as access to care and study drugs WZ3146 between all participants, but the authors were not able to account for the socioeconomic and other differences that they believed led to more Blackpatients discontinuing than other patients and the resulting lower response rate in these patients. Patients had substantial mean increases in CD4 cell counts at week 48 in both treatment groups, irrespective of gender or race. Mean increases in CD4 cell count were generally similar between subgroups, with the exception of higher CD4 cell count increases in White compared with Black patients.
This observation contrasts with an analysis of five AIDS Clinical Trials Group trials, where Black patients experienced a greater CD4 cell count increase from baseline, despite their higher risk of virological failure, compared with White patients. Although the median RPV exposure was higher in female patients and Asian patients, the range of exposures CYC202 Seliciclib observed in these two subgroups was similar to that of the overall population. Furthermore, there was no relationship between higher exposures and safety parameters. This small difference in mean exposure was, therefore, not considered to be of clinical relevance or sufficient to explain differences in outcome by race or gender. Safety findings were generally similar across gender and race subgroups.
There were, however, differences Ki16425 in the incidence of some individual treatment related AEs between certain subgroups. Because of the lack of statistical power, it is difficult to draw conclusions about the relevance of these differences, but the higher incidence of nausea in women has been previously reported for other ARVs, for example with etravirine combined with darunavir/ritonavir based treatment in ARV experienced patients and with lopinavir/ritonavir and atazanavir/ ritonavir in ARV naïve patients. There was a lower incidence of grade 2 4 treatment related AEs, rash, dizziness, abnormal dreams/nightmares and lipid related abnormalities for RPV than for EFV in both genders and all races, consistent with observations in the overall trial.
The ECHO and THRIVE trials had a relatively diverse patient population and the trials were successful from the perspective that a relatively high proportion of female patients were enrolled. Limitations of this study include the fact that there were small numbers of participants in some of the subgroups. As male and White patients were overrepresented, this prevented a more in depth assessment of the possible effects of gender and race on RPV efficacy and safety. A large observational cohort study including more women and patients from different ethnicities would be feasible, given that these subgroups account for a substantial proportion of HIV 1 infected patients world wide, and despite the limitations inherent in observational studies, useful information on potential subgroup differences could be provided. In conclusion, pooled data from ECHO and THRIVE suggest that there were no differences in response rates by gender for either RPV or EFV, although there were